BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIATRONIX V3D-CARDIAC, REVISION 1.0

    K Number: K083293 · Decision Dec 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    8
    Review Days
    25

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    Basic Information

    Device Name
    VIATRONIX V3D-CARDIAC, REVISION 1.0
    K Number
    K083293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viatronix, Inc.
    Date Received
    November 10, 2008
    Decision Date
    December 5, 2008
    Product Code
    JAK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAK System, X-Ray, Tomography, Computed

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    Other Clearances by Viatronix, Inc.

    K Number Device Name
    K040126 VIATRONIX V3D COLON, REVISION 1.3
    K033361 VIATRONIX V3D VASCULAR, REVISION 1.0
    K032483 VIATRONIX V3D EXPLORER, REVISION 1.2
    K022789 VIATRONIX V3D EXPLORER
    K020658 VIATRONIX V3D COLON
    K013146 VIATRONIC V3D CALCIUM SCORING
    K002780 VIATRONIX VISUALIZATION SYSTEM (VVS)